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Completed

NCT Number: NCT05479734

Promoting Resilience and Lowering Risk in Early Childhood

An intervention study to provide in-the-moment parenting tips with the goal of increasing healthy parent-child interactions leading to resiliency in high-risk children. Specifically, in a sample of parents participating in HV programs, the investigators will use a smartphone app (mHealth app) to deliver daily tailored messages with tips on monitoring and promoting child development. Daily assessments of parents' emotions, parenting behaviors, and interactions with their children will also be collected via the app. During the 4-week EMA study, parents will receive either 2 weeks of the mHealth intervention + EMA data collection followed by 2 weeks of only EMA data collection or to receive 2 weeks of only EMA data collection followed by 2 weeks of mHealth intervention + EMA data collection.

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Key information

Age range

0 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oklahoma Health Science Center- Center on Child Abuse and Neglect

Oklahoma City, Oklahoma, 73104, United States

About this study

This is an intervention study to provide in-the-moment parenting tips with the goal of educating parents about monitoring and promoting child development, thereby increasing healthy parent-child interactions leading to resiliency in high-risk children. Specifically, in a sample of parents participating in a HV program, the investigators will use a smartphone app (mHealth app) to deliver twice-daily tailored messages with tips on monitoring and promoting child development. Ecological momentary assessments (EMA) of parents' emotions, parenting behaviors, and interactions with their children will also be collected via the mHealth app. Building off previous work the investigators expect that parents will evidence greater engagement in positive parenting practices on days when they receive the mobile-based parenting tips and strategies relative to on days when they do not receive this content.

The investigators hypothesize that in-the-moment parenting tips delivered around peak times of parent-child interactions (i.e., before work/school, mealtimes, and bedtime) will promote positive parenting practices in a sample of parents at increased risk of adversity exposure. The investigators aim to use EMA methodology to measure both group level differences (i.e., intervention vs. services as usual) and within-person fluctuations in harsh parenting, children's emotional and behavioral functioning, and positive parenting practices. The study will evaluate the following aims and hypotheses:

Aim 1. Conduct a 2-arm, randomized, controlled crossover trial to examine the feasibility and effectiveness of a mobile-based parenting app with parents participating in HV services.

Hypothesis 1a. Parents will report high rates of satisfaction and usability. Hypothesis 1b. Parents will evidence greater engagement in positive parenting practices on days when they receive the mobile-based parenting tips and strategies relative to days when they do not receive this content.

Hypothesis 1c. Groups will evidence increases in positive parenting subscale scores after a month of app engagement.

Aim 2. Utilize EMA data and follow-up assessments to examine the impact of positive parenting practices on the promotion of child development.

Hypothesis 2a. Children will demonstrate less challenging and more positive behavioral functioning on days when their parents receive positive parenting tips.

Hypothesis 2b. Groups will evidence increases in developmental scores after a month of app engagement.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any new or currently enrolled parent in Oklahoma or Tulsa County in MIECHV-funded home visiting programs.

Exclusion criteria

  • Parents residing outside of Oklahoma or Tulsa Counties will not be recruited (although if they move to another county between baseline and follow-up, they may be eligible to complete the follow-up survey at the discretion of the Principal Investigator).
  • Parents who cannot read/speak English or Spanish at an 8th-grade level or higher will not be recruited.
  • Parents under age 16 will not be recruited. Parents ages 16-17 meeting other eligibility requirements may be recruited using the assent form with signatures from both of his/her parents.

Treatment and study plan

mHealth Intervention

Behavioral

A smartphone app (mHealth app) will deliver daily tailored messages with tips on monitoring and promoting child development and positive parenting tips.

Primary outcomes

  1. Positive Parenting Practices: EMA Data Positive Parenting Activity Engagement

    Time frame: Daily EMA Data (28 days)

    Participants select the positive parenting activities they engaged in with their child each day during the EMA study (0 is the lowest and represents no engagement in positive parenting practices and a higher number reflects more activities reported). Analyses compared average activity counts during periods with and without app-delivered parenting tips.

  2. Parenting Behavior: Alabama Parenting Questionnaire- Positive Parenting Subscale

    Time frame: Change from baseline to post-intervention

    The Alabama Parenting Questionnaire contains 3 subscales previously used with parents of young children that represent different dimensions of parenting. Each item is rated on a 1 (never) to 5 (always) Likert scale. A higher score on each subscale represents more engagement in that parenting behavior. This analysis focused on the Positive Parenting Subscale (12 items; score range: 12-60).

  3. Positive Parenting Practices: EMA Data Time Spent With Child Daily (in Hours)

    Time frame: Daily EMA Data (28 days)

    Mean number of hours spent with the child daily during the periods with and without app-delivered parenting tips.

  4. Helped me Interact Positively With Child

    Time frame: Post-intervention Assessment

    Participants responded on a scale from Not at all helpful (scored -1) to Extremely helpful (scored 3).

  5. Interest in Using the App in the Future

    Time frame: Post-Intervention Assessment

    Participants responded on a scale from Not at all interested (scored -1) to Extremely interested (scored 3).

  6. Recommend the App to a Friend

    Time frame: Post-Intervention Assessment

    Participants responded on a scale from Extremely unlikely (scored -3) to Extremely likely (scored 3).

Secondary outcomes

  1. General Child Development Score

    Time frame: Change from baseline to post-intervention

    Developmental Profiles-4 parent/caregiver interview contains five subscales: social-emotional, physical, communication, cognitive, and adaptive behavior. Each subscale score is age standardized with an average of 100 and a standard deviation of 15 (minimum score of 40, maximum score of 160). The General Development Score used in this analysis represents a standardized composite of the 5 subscale scores (minimum score of 46, maximum score of 150). A higher composite score indicates more advanced child development.

  2. Child Behavior: EMA Challenging Child Behaviors

    Time frame: Daily EMA Data (28 days)

    Parents report the number of challenging (difficult to manage) child behaviors daily. Analyses compared average behavior counts during periods with and without app-delivered parenting tips.

  3. Child Behavior: EMA Positive Child Behaviors

    Time frame: Daily EMA Data (28 days)

    Parents report the number of positive ("good") child behaviors daily. Analyses compared average behavior counts during periods with and without app-delivered parenting tips.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

Promoting Resilience and Lowering Risk in Early Childhood: An mHealth Intervention Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 29, 2022
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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